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Johnson & Johnson, through its operating companies, is the world’s most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 275 operating companies in more than 60 countries employing approximately 128,700 employees. With Global sales of USD $74.3 billion in 2014, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.

In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently managed and report into their respective Global business segments.

Job Title : Officer QC

Requisition ID : 1700185202W

Locations : Greater Mumbai, India

Sector : Pharma

Objectives & Responsibilities:

  • The Data reviewer is responsible for performing analyses and investigations according to established methodology and implementation of established procedures.

Main Duties/Additional Duties/Sphere of authority:

  • Personnel
  • Perform data review in accordance with the cGMP/Data Integrity requirements. Analyzing the data with respect to ALCOA principles
  • Thorough knowledge in the area of stability testing and all the applicable regulations
  • Ensure proper planning for execution of review within window.
  • To ensure immediate escalation of issues not in conformity with applicable procedures /policies etc.
  • Results reviewing into the applicable LIMS system as per established procedures.
  • Knowledge of maintenance and qualification/calibration (execute) of lab equipments. Knowledge of FMEA analysis, risk analysis for instrument qualification
  • Up to date knowledge of current regulatory requirements and pharmacopoeil updates
  • Technical/scientific support to other labs within the premise.
  • Participate in project teams as analytical technical team member.
  • Attend (in-house) seminars, scientific meetings in own field.
  • Comply with the applicable responsibilities according to various procedures.
  • Training of colleagues (if applicable).
  • Initiate and document deviations in applicable Event Tracking System in timely manner.
  • Initiate (if applicable) and implement CAPA’s in timely manner.
  • Compilation of work instructions and standard operating procedures.
  • Initiate applicable change requests according to the procedures.
  • Execute the tasks according to the cGMP guidelines.
  • Following Procedures & self-upgrade knowledge of key areas.
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Employee safety and health

  • Ensure that respective guidelines and SOPs are followed
 

Environmental Care

  • Ensure that respective guidelines and SOPs are followed
 

Quality

  • Ensure that respective guidelines and SOPs are followed
 

Financial management

  • Ensure that respective guidelines / practices are followed
  • Identify cost saving opportunities
 

Business Policy

  • Follow all applicable company business policies.
 

MIS  Policy

  • Follow all applicable company business policies.

Credo and Leadership Imperatives

  • Respect and make the credo values respected.
  • Stimulate and encourage new ideas and improvement processes.
  • Practice and implement Leadership imperatives (connect, deliver, lead, and shape) for customer satisfaction, innovation, mastering complexity, collaboration.
  • Cooperate efficiently with the different partners.

Qualifications

Minimum Qualification for the position:
  • Science/Pharmacy Graduate.
Deputy Arrangement (active/Passive):

Active representation: the employee represents the following persons in case of absence

Passive representation: in absence, the employee is represented by
  • Active representation:
    • Data reviewers within SO lab
  • Passive representation:
    • Other data reviewers within SO lab

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